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New treatment option for Breast Neoplasm Female
Official title A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
ClinicalTrials.gov ID: NCT05417516
What this study is testing
- What it's testing
- The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
- Phase 3: a large, late-stage study
- Time commitment: about 1 week
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 120, women only
You may be able to join if
- For inclusion in this study, patients must fulfill all of the following criteria:
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging...
- Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a...
You likely can't join if
- Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size \>3cm in greatest diameter on pathological examination.
- Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least...
- Evidence of a DCIS component \> 3cm
See the full eligibility criteria
- For inclusion in this study, patients must fulfill all of the following criteria:
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
- Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours...
- Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size \>3cm in greatest diameter on pathological examination.
- Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal...
- Evidence of a DCIS component \> 3cm
- Lobular carcinoma only.
- More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
- Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
- History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
- Known pregnancy or currently lactating.
- Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- Inability to plan the patient for the experimental technique.
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Hurstville, New South Wales, Australia
- North Sydney, New South Wales, Australia
- Bundaberg, Queensland, Australia
- Southport, Queensland, Australia
- Tugun, Queensland, Australia
- Urraween, Queensland, Australia
- Adelaide, South Australia, Australia
- Bedford Park, South Australia, Australia
- Wembley, Washington, Australia
- Murdoch, Western Austrailia, Australia
- Nedlands, Western Australia, Australia
- Calgary, Alberta, Canada
- Victoria, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Barrie, Ontario, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Sault Ste. Marie, Ontario, Canada
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 week per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 50 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Hurstville, New South Wales, Australia; North Sydney, New South Wales, Australia; Bundaberg, Queensland, Australia; Southport, Queensland, Australia; Tugun, Queensland, Australia and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.